Expanding Transparency

Global Disclosure Clinical trials are conducted in almost every country in the world, each with its own health authority and regulations. One aspect of these regulations is clinical trials transparency with over 90 countries that have related requirements.

Scope of Disclosure

While trial registration started with the HOPE Act of 1988, it was not until 2005 when the ICMJE[2] and the US State of Maine both required the prospective registration of clinical protocols, that the number of protocol summaries publicly available started to grow significantly. Subsequent regulations have increased the number of trials posted in the US and EU alone to over 250,000, with an additional 150,000+ studies posted on other international registries.

Documents & Data

As the number of trial registries and countries with disclosure regulations grew, the scope of clinical information that was required to be published increased substantially. Until 2008, only a summary of the clinical protocol was required, followed by tabular results in 2008 and then a considerably expanded scope of clinical data and documents since 2012.

Transparency Advocates and Organizations In parallel to the evolving clinical trial disclosure regulations, transparency advocates and a range of organizations have established disclosure standards based on their perspectives. These include:

Global organizations such as the World Health Organization (WHO) and the World Medical Association (WMA)

Journals such as the British Medical Journal (BMJ), Lancet, the New England Journal of Medicine (NEJM), and STATNews

Transparency advocates such as Dr. Jennifer Miller at Bioethics International, Dr. Síle Lane at Sense about Science/AllTrials, and Ben Goldacre at the EBM DataLabs

The key difference between the transparency perspectives of these groups and the legal disclosure requirements of most countries, is the expected scope of disclosure. For example, most country regulations do not require the posting of protocol or results data for Phase I studies, and usually do not require the disclosure of data for older studies. The WHO, the WMA, and transparency advocates however typically expect that clinical data for all studies in humans should be publicly available, including all Phase I studies, with some advocating for the disclosure of results for any product currently available in the market.

Summary

The number of studies that have at least some data publicly available has grown tremendously in the past 10 years, with an increasing scope of information that is required by a greater range of countries on ever more trial registries. Although the volume of disclosed data is steadily going up, there are calls for broader transparency of consistent and high-quality data to be released more quickly and in greater detail.

Operational Risks The next blog in this series will consider the operational risks associated with clinical trial transparency.

[1] The 200 countries include territories and regions. Source: clinicaltrials.gov May 9 2017